Qualified Person

Discover International; Nouvelle-Aquitaine; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Discover International is seeking a Pharmacist/Qualified Person for its sterile pharmaceutical manufacturing site in France. You will oversee GMP-compliant quality systems, certify customer batches, and drive continuous improvement within a European Centre of Excellence for development, filling and finishing of biological products.

The role requires a Master’s degree in Pharmacy, 3+ years in a QA/QP function, strong GMP/regulatory knowledge and fluency in English and French.

Qualifications

• Pharmacist with a Master’s degree (Bac +5).
• 3+ years in a Quality/QP role in pharma.
• Experience with process qualification and validation.
• Strong GMP and pharmaceutical regulation knowledge.
• Experience with deviations, CAPAs and quality investigations.
• Fluent English and French required.
• Excellent communication, analytical and organizational skills.
• Able to manage external stakeholders.

Responsabilités

• Oversee validation, management and monitoring of raw materials.
• Certify customer batches manufactured on site.
• Manage deviations, CAPAs and quality investigations.
• Support customer relationships regarding quality issues.
• Ensure GMP compliance and site quality procedures.
• Approve key QP documentation.
• Support regulatory and customer audits.
• Collaborate with Production, Quality, Validation, Metrology and Maintenance.
• Drive continuous improvement of the Quality Management System.
• Assist with customer complaints investigations.

Connaissances

GMP knowledge

Quality investigations

CAPA management

Regulatory knowledge

Stakeholder management

Communication skills

Analytical skills

Organizational skills

Quality documentation

Formation

Master's degree (Bac+5)

Description du poste

An exciting opportunity for a Pharmacist / Qualified Person to join a leading sterile pharmaceutical manufacturing site within a global organisation.

The site is a European Centre of Excellence specialising in the development, filling and finishing of biological products for clinical trials, across vials, syringes and cartridges.

Key Responsibilities

• Oversee the validation, management and monitoring of raw materials


• Confirm and certify customer batches manufactured on site


• Manage deviations, CAPAs and quality investigations


• Support customer relationships regarding quality issues and deviations


• Ensure compliance with GMP, site procedures and quality requirements


• Approve and sign key quality documentation within QP responsibilities


• Support regulatory and customer audits


• Work closely with Production, Quality, Validation, Metrology and Maintenance teams


• Support continuous improvement of the site's Quality Management System


• Support customer complaints and related investigations

Requirements

• Pharmacist with a Master's degree (Bac +5)


• 3+ years' experience in a similar pharmaceutical Quality/QP role


• Experience with process qualification and validation


• Strong knowledge of GMP and pharmaceutical regulations


• Experience with deviations, CAPAs and quality investigations


• Sterile manufacturing experience is advantageous


• Strong knowledge of pharmaceutical quality and qualification


• Fluent English and French is a necessity


• Strong communication, analytical and organizational skills


• Ability to manage external stakeholders effectively